EPICIMPOC: Enhanced, Personalized and Integrated Care for Infection Management at the Point-Of-Care

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT04013737
Collaborator
(none)
33
1
29.3
1.1

Study Details

Study Description

Brief Summary

Antimicrobials (drugs that kill or stop the growth of microorganisms including bacteria, thereby treating infections) commonly used to treat patients with infections are becoming less effective over time as bacteria develop resistance to them. Antimicrobial usage itself can lead to development and spread of antimicrobial resistance. Antimicrobial resistance is now a major threat to patient safety. To conserve the effectiveness of antimicrobials the investigator need to develop ways to use them more sensibly healthcare professionals who diagnose and treat infections must be able to access antimicrobial guidelines and test results at the patient bedside. This needs to be provided rapidly and with support to make sure that the decisions on prescribing antimicrobials are the best that can be made.

Condition or Disease Intervention/Treatment Phase
  • Device: EPIC IMPOC

Detailed Description

Prototype software to achieve this has been developed through collaboration between healthcare professionals and biomedical engineers. This prototype software (run on a mobile device) retrieves patient results from various laboratory and clinical databases (securely within the Trust firewall) and displays this to the clinician making the prescribing decision. Furthermore a machine learning algorithm is applied to the data, and similar anonymised historical cases (and the antimicrobials prescribed and the clinical outcomes) are also displayed to the clinician to further inform their decision making. The prototype has been designed for use in intensive care, where the risk of infection is high, but through the research project detailed here, the software will be developed and validated across other areas of hospital patient care. Furthermore there is a key need to engage patients with how decisions are made around antimicrobial prescribing. The investigator propose to adapt the prototype to meet these needs. This system should improve patient safety and help preserve the effectiveness of existing antimicrobials

Study Design

Study Type:
Observational
Actual Enrollment :
33 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Enhanced, Personalized and Integrated Care for Infection Management at the Point-Of-Care
Actual Study Start Date :
Feb 28, 2017
Actual Primary Completion Date :
Aug 8, 2019
Actual Study Completion Date :
Aug 8, 2019

Arms and Interventions

Arm Intervention/Treatment
Patients and Public

Exploration of patient and public engagement with antibiotic decision making in secondary care. Prospective evaluation of a co-designed intervention to support enhanced knowledge and understanding of infections and their management.

Device: EPIC IMPOC
Clinical Decision Support System for antibiotic prescribing.

Prescribers

Quantitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making.

Device: EPIC IMPOC
Clinical Decision Support System for antibiotic prescribing.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Appropriate Antimicrobial Prescriptions Recommended [Single prescription at the time of antimicrobial prescribing assessment (e.g. at the time antibiotics were prescribed)]

    This will be measured by assessing the appropriateness of prescriptions recommended by the system compared to current clinical practice. Appropriateness is determined by evaluating prescribing against current clinical guidelines or infection expert opinion on best practice and is expressed as a proportion of the total number of antibiotic prescriptions made. Each individual patient has a single antibiotic prescription evaluated.

  2. Evaluation of Effectiveness Assessed by User Acceptance of the Device [Single time point before and after use of the device in the study]

    This was assessment was a single time point at baseline (Pre-intervention) and single time point after use of the device in the study. Scores were pre-determined based on anticipated answers provided by participants pre- and post- intervention using a bespoke mark scheme (https://aricjournal.biomedcentral.com/articles/10.1186/s13756-018-0333-1). Participants could score between 0 (lowest) and 13 (highest) marks based on their responses to questions assessing knowledge and understanding.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

(i) healthcare professionals for evaluation phases: Have read the PIL and consent to participate in the study

(ii) patients for whom the clinician chooses to use the POC DSS as a resource when prescribing antimicrobials: Adult patients > 18 years old Being managed for infection outside of the critical care setting in Imperial College Healthcare NHS Trust Deemed appropriate for management with POC DSS by attending physician Prescribed antimicrobial agents outside of the critical care setting in last 5 days

(iii) Prescriber / healthcare professional for using POC DSS: Trained Healthcare Professional Working within wards under assessment Deemed suitable for recruitment by senior member of their team

Exclusion Criteria:

(i) healthcare professionals: Do not wish to participate in the study Working across wards which is acting as a control ward Deemed no suitable for recruitment by a senior member of their team Non-permanent member of the Trust Information governance training not up-to-date

(ii) patients recruits Critical care patients Paediatric patients < 18 years old Deemed not suitable for management using POC DSS by attending physician On palliative care, end of life pathway Prisoners / young offenders in custody of HM Prison Service Involved in current research or have recently been involved in any research prior to recruitment (last 3 months)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College London London United Kingdom W12 0NN

Sponsors and Collaborators

  • Imperial College London

Investigators

  • Principal Investigator: Alison Holmes, Professor

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT04013737
Other Study ID Numbers:
  • 16HH3526
First Posted:
Jul 10, 2019
Last Update Posted:
Aug 31, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imperial College London
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Professionals recruited = 15 Patients recruited for prospective study of engagement tool = 18
Pre-assignment Detail 15 healthcare professionals were recruited who would be using the tool to make antibiotic prescribing decisions. 18 patients were enrolled in the pre- post- assessment of the impact of a patient-communication tool within the system on knowledge and understanding of their infection and its management.
Arm/Group Title Patients and Public Prescribers
Arm/Group Description Prospective evaluation of knowledge and understanding of infections pre- and post- a patient communication intervention. Quantitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making. EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing.
Period Title: Overall Study
STARTED 18 15
COMPLETED 18 15
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Patients and Public Prescribers Total
Arm/Group Description Exploration of patient and public engagement with antibiotic decision making in secondary care. Qualitative evaluation and co-design of interventions. Prospective evaluation of intervention. EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing. Quantitative and qualitative evaluation of the impact of using a clinical decision support system to support antibiotic decision making. EPIC IMPOC: Clinical Decision Support System for antibiotic prescribing. Total of all reporting groups
Overall Participants 18 15 33
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]
66
66
Sex: Female, Male (Count of Participants)
Female
8
44.4%
7
46.7%
15
45.5%
Male
10
55.6%
8
53.3%
18
54.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%

Outcome Measures

1. Primary Outcome
Title Percentage of Appropriate Antimicrobial Prescriptions Recommended
Description This will be measured by assessing the appropriateness of prescriptions recommended by the system compared to current clinical practice. Appropriateness is determined by evaluating prescribing against current clinical guidelines or infection expert opinion on best practice and is expressed as a proportion of the total number of antibiotic prescriptions made. Each individual patient has a single antibiotic prescription evaluated.
Time Frame Single prescription at the time of antimicrobial prescribing assessment (e.g. at the time antibiotics were prescribed)

Outcome Measure Data

Analysis Population Description
15 prescribers made 224 antimicrobial prescriptions during the study period which were analysed for the outcome measure.
Arm/Group Title Appropriateness of Antibiotic Prescribing
Arm/Group Description Proportion of appropriate recommendations made using the case-based-reasoning algorithm out of 224 prescriptions input into the system by participants.
Measure Participants 15
Measure Prescriptions made by participants 224
Number [percentage of prescriptions appropriate]
90
2. Primary Outcome
Title Evaluation of Effectiveness Assessed by User Acceptance of the Device
Description This was assessment was a single time point at baseline (Pre-intervention) and single time point after use of the device in the study. Scores were pre-determined based on anticipated answers provided by participants pre- and post- intervention using a bespoke mark scheme (https://aricjournal.biomedcentral.com/articles/10.1186/s13756-018-0333-1). Participants could score between 0 (lowest) and 13 (highest) marks based on their responses to questions assessing knowledge and understanding.
Time Frame Single time point before and after use of the device in the study

Outcome Measure Data

Analysis Population Description
Patients in hospital.
Arm/Group Title Improvement in Short Term Knowledge/Understanding
Arm/Group Description Compared using pre- and post- intervention questionnaire
Measure Participants 18
Pre-intervention
3
Post-intervention
10

Adverse Events

Time Frame Not assessed
Adverse Event Reporting Description Adverse events were not assessed as this was not an observational study.
Arm/Group Title
Arm/Group Description
All Cause Mortality
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Serious Adverse Events
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Affected / at Risk (%) # Events
Total 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Head of Operations
Organization Health Protection Research Unit in HCAI and AMR, Imperial College London
Phone 020 3313 2732
Email head.ops@imperial.ac.uk
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT04013737
Other Study ID Numbers:
  • 16HH3526
First Posted:
Jul 10, 2019
Last Update Posted:
Aug 31, 2021
Last Verified:
Aug 1, 2021